Depomed, Inc. v. Actavis Elizabeth LLC
| Decision Date | 18 August 2014 |
| Docket Number | Civil Action No. 12-1358 (JAP) |
| Parties | DEPOMED, INC, Plaintiff(s), v. ACTAVIS ELIZABETH LLC, et al. Defendant(s). |
| Court | U.S. District Court — District of New Jersey |
***REDACTED***
**FILED UNDER TEMPORARY SEAL** (pending motion to seal)-
This is a Hatch-Waxman patent infringement action brought by Plaintiff Depomed, Inc. ("Plaintiff" or "Depomed") against defendants, Actavis Elizabeth LLC and Actavis Inc. (together, "Defendant" or "Actavis") in connection with Defendant's filing of an Abbreviated New Drug Application ("ANDA") seeking approval to sell generic gabapentin once-daily tablets. A bench trial was held May 12, 2014 to May 20, 2014, and the parties presented evidence on the questions of whether Defendant infringes any of the asserted claims in the seven patents-in-suit and whether the asserted claims are obvious and/or indefinite. This Opinion constitutes the Court's findings of fact and conclusions of law. As set forth below, the Court finds that Plaintiff has shown by the preponderance of the evidence that Defendant infringes the asserted claims, and further finds that Defendants have not shown by clear and convincing evidence that the asserted claims are invalid.
Plaintiff Depomed Inc. is a corporation organized under the laws of California, with a principal place of business in Newark, CA. Final Pretrial Order ("FPO"), Stipulated Facts ( ) ¶1. Depomed, a specialty pharmaceutical company, is the holder of New Drug Application ("NDA") No. 22-544, by which the United States Food and Drug Administration ("FDA") granted approval for tablets containing the active ingredient 1-(aminomethyl) cyclohexaneacetic acid (known as "gabapentin"). Id. ¶ 2; Tr.1 373:8. These gabapentin tablets are sold by Depomed in the United States under the brand name Gralise in dosage sizes of 300 mg and 600 mg. Stip. Facts. ¶ 3. Gralise was approved by the FDA for treatment of post-herpetic neuralgia ("PHN"). Id. ¶ 106. Presently, Gralise is the only once-a-day gabapentin product indicated for PHN available in the marketplace that is approved for commercial sale by FDA. Id. ¶ 107. Depomed began selling Gralise in or about October of 2011. Id. ¶ 108.
Defendant Actavis LLC is a limited liability corporation organized and existing under the laws of the State of Delaware, having a place of business in Morristown, New Jersey. Id. ¶ 4. Defendant Actavis Elizabeth LLC is a limited liability company that is wholly owned by Actavis LLC. Id. ¶ 5. Actavis Elizabeth LLC is organized and exists under the laws of the State of State of Delaware, having a principal place of business in Elizabeth, New Jersey. Id. On October 31, 2011, Defendant submitted ANDA No. 203611 with the FDA seeking approval to market generic gabapentin extended-release oral tablets in dosage strengths of 300 mg and 600 mg (the "ANDA product") prior to the expiration of the patents-in-suit. Id. ¶ 14.
The present action is for patent infringement under 35 U.S.C. § 271(e)(2)(A), 271(a), (b), and (c) and under the Hatch-Waxman Act, codified in part at 21 U.S.C. § 355(j). Defendant has counterclaimed for a declaration that it does not and will not infringe any valid claim of the patents-in-suit, and for a declaration that patents-in-suit are invalid.
As set forth below, Depomed asserts against Actavis a number of composition and method claims. These claims are directed to a type of extended-release gabapentin oral dosage form that releases gabapentin in the stomach over several hours and delivers the drug in such a way that an individual achieves certain blood concentrations of the drug and that the drug has a therapeutic effect:
1. Platform/Gastric Retention Patent
United States Patent No. 6,635,280 (the "'280 Patent"), entitled "Extending the Duration of Drug Release Within the Stomach During the Fed Mode," issued on October 21, 2003, to Depomed from a patent application filed on November 6, 2001, as a continuation from United States Patent No. 6,340,475 ("the '475 Patent"). Stip. Facts ¶¶ 8, 50. FDA's publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the "Orange Book") identifies the expiration date of the '280 Patent as September 19, 2016. Id. at ¶ 8.
Depomed has asserted claims 1, 12, 14 and 45 of the '280 Patent in this case.2 Stip. Facts ¶ 51.
Claim 1 of the '280 Patent is directed to:
A controlled release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising one or more polymers forming a solid polymeric matrix with said drug incorporated therein at a weight ratio of drug to polymer of from 15:85 to 80:20, said dosage form being one that when swollen in a dimensionally unrestricted manner as a result of imbibition of water is of a size exceeding the pyloric diameter in the fed mode to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug after such immersion, and that remains substantially intact until substantially all of said drug is released.
Stip. Facts¶ 53, '280 Patent (JTX 2) at col. 17, ll. 45-61. Claims 12, 14, and 45 depend from claim 1. Claim 12 adds the limitation that the "polymeric matrix is formed of poly(ethylene oxide) at a molecular weight in the range of about 5,000,000 to about 8,000,000." Stip. Facts. ¶ 59. Claim 14 adds the limitation that the "polymeric matrix upon immersion in gastric fluid retains at least about 60% of said drug one hour after such immersion." Id. at ¶ 60. Claim 45 adds the limitation that the "dosage form releases substantially all of said drug within about ten hours after immersion in gastric fluid." Id. at ¶ 61.2. Oval/Gastric Retention Patent
United States Patent No. 6,488,962 (the "'962 Patent"), entitled "Tablet Shapes To Enhance Gastric Retention of Swellable Controlled-Release Oral Dosage Forms", issued to Depomed as assignee of the inventors on December 3, 2002, from a patent application filed on June 20, 2000. Stip. Facts ¶¶ 7, 40. The Orange Book identifies the expiration date of the '962 Patent as June 20, 2020. Id. ¶ 7. Plaintiff's product Gralise is an embodiment of the asserted claims of the '962 Patent. Id. ¶ 111.
None of the four asserted claims from this patent have been asserted against Defendant's 300 mg dosage form; claims 5, 8, 10, and 13, from the '962 Patent are being asserted against the 600 mg tablet only. Claims 5, 8, and 10 are dependent upon claim 1. Claim 13 depends from Claim 10.
Independent claim 1 of the '962 patent reads as follows:
A controlled-release oral drug dosage form for releasing a drug into at least a portion of a region defined by the stomach and the upper gastrointestinal tract, said dosage form consisting essentially of a solid monolithic matrix with said drug contained therein, said matrix being non-circular in shape and having first and second orthogonal axes of unequal length, said matrix being one that swells in an unrestricted manner along both such axes upon imbibition of water, the longer such axis having a maximum length of 3.0 cm when said matrix is unswollen, and the shorter such axis achieving a minimum length of 1.2 cm within one hour of immersion of said dosage form in water and wherein said matrix has a shape which when projected onto a plane, is either an oval or a parallelogram.
JTX 1 at col. 11, ll. 14-26, Stip. Facts ¶ 43. Claims 5, 8, and 10 add the following limitations, respectively: (i) the dosage form where the "shorter axis has a length of 0.7 cm to 1.5 cm when said matrix is unswollen"; (ii) the dosage form where the "longer axis has a maximum length of 2.5 cm when said matrix is unswollen"; and (iii) where the "matrix is awater-swellable polymer". JTX 1 at col. 11, ll. 38-39, 47-48 and 53-54; Stip. Facts¶¶ 42, 46-48. Claim 13 depends from claim 10, and adds the following limitation: the dosage form where the "water-swellable polymer is a member selected from the group consisting of poly(ethylene oxide), hydroxypropylmethyl cellulose, and hydroxyethyl cellulose". JTX 1 at col. 12, ll. 2-5; Stip. Facts ¶¶ 42, 49.
3. The Gabapentin Patents3
United States Patent No. 7,438,927 (the "'927 Patent"), entitled "Methods of Treatment Using a Gastric Retained Gabapentin Dosage," issued to Depomed on October 21, 2008, from a patent application filed on October 25, 2002. Stip. Facts ¶¶ 9, 62. The Orange Book identifies the expiration date of the '927 patent as February 26, 2024. Id. ¶ 9. The use of Gralise in treating post-herpetic neuralgia ("PHN") embodies the asserted claims of the '927 Patent. Id. at ¶ 112.
Depomed has asserted claims 18, 25, 26, 34, 61 and 62 of the '927 Patent in this action. Id. ¶ 63. Each of the asserted claims depend from either of two independent claims - claim 17 (claims 18, 25, 26, 61) or claim 33 (claims 26, 62). Neither claim 17 or 33 is asserted in this litigation.
Claim 17 of the '927 Patent is directed to:
A method of treating neuropathic pain in a mammal comprising administering a therapeutically effective amount of a daily dosage of about 100 mg to about 4800 mg of gabapentin or a pharmaceutically acceptable salt thereof, dispersed in a gastric retained dosage form to the mammal in which a fed mode has been induced, wherein the dosage form comprises a single polymer matrix comprising at least one swellable hydrophilic polymerthat swells in a dimensionally unrestrained manner by imbibing water to increase its size to promote gastric retention of the dosage form in the stomach of the mammal,...
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